MAUDE Adverse Event Report: MEDARTIS INC. STRATUM FOOT PLATING SYSTEM; PLATE

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/26/2023

Event Type  Injury  

Event Description

"i believe the original surgery took place (b)(6) at (b)(6) and will confirm with the surgeon.He let me know on (b)(6) that a patient with our 1st mpj stratum plate had an infection 6 months later at the site of the hardware.On (b)(6) the hardware was removed.He simply asked me if our company needs to know about the infection since it was at the site of the implants.Updated information received 12/22/2023, these products were originally implanted at (b)(6) on (b)(6) 2023 and explanted at (b)(6) on (b)(6) 2023 due to an infection at the implant site.

Manufacturer Narrative

If additional information is received that changes the outcome of the investigation a follow up report will be filed.

• Brand Name: STRATUM FOOT PLATING SYSTEM
• Type of Device: PLATE
• Manufacturer (Section D): MEDARTIS INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer (Section G): MEDARTIS INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer Contact: travis christman ; 1195 polk drive; warsaw, IN 46582
• MDR Report Key: 18434431
• MDR Text Key: 331866308
• Report Number: 3009540749-2023-00008
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention